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JMIR Res Protoc.2021 Dec;10(12):e33104.


Effects of Prosthetic Rehabilitation on Temporomandibular Disorders: Protocol for a Randomized Controlled Trial.

PMID: 34951603




BACKGROUND: Loss of teeth or occlusal imbalance is one of the proposed dental risk factors for temporomandibular disorders (TMDs). Losing some non-free-end teeth cause the original occluding tooth/teeth to supraerupt from the original upright position and causes neighboring tooth/teeth to shift in an angle, causing biomechanical imbalance on the mandible. Based on these sequelae, rehabilitation of missing teeth is the first step in managing TMD in edentulous patients. Even though the prevalence of TMD in association with edentulism and in rehabilitated patients has been increasing, proper guidelines for the management of such cases have not been established. This study describes the protocol to analyze the effect of prosthetic rehabilitation on patients with TMD.



OBJECTIVE: This study aims to determine the effectiveness of prosthetic rehabilitation in the reduction of pain in edentulous patients with TMD and to determine the effect of the span of edentulism, the number of quadrants involved, pathological migration, the type of Kennedy classification, and the prosthetic status on temporomandibular joint dysfunction signs and symptoms.


この無作為化比較試験では、顎関節症と診断された300人の患者を、無歯顎状態のタイプに基づいて、3つの介入群のいずれかに分類する。介入群は、(1)部分的無歯顎のアーチ。ケネディクラスIおよびII(スプリントを使用しない補綴リハビリテーション)、(2)部分無歯顎のアーチ。ケネディクラスIIIおよびIV(スプリントを使用した補綴リハビリテーション)、および(3)完全無歯顎のアーチ(スプリントを使用しない補綴リハビリテーション)です。これら3つの介入群には、それぞれ対応する対照群があり、対症療法と包括的なカウンセリングを受けます。主要評価項目は痛みと筋電図、副次評価項目は痛みの描画、Graded Chronic Pain Scale、Jaw Functional Limitation Scale、Oral Behaviours Checklist、抑うつ、身体症状、不安などである。アウトカムの測定は、ベースライン時と、24時間後、7日後、28日後、3ヶ月後に記録されます。

METHODS: In this randomized controlled trial, 300 patients diagnosed with TMD will be grouped into one of the three interventional groups based on the type of their edentulous state. The interventional groups are (1) partially edentulous arch: Kennedy Class I and II (prosthetic rehabilitation without splint); (2) partially edentulous arch: Kennedy Class III and IV (prosthetic rehabilitation with a splint); and (3) completely edentulous arches (prosthetic rehabilitation without splint). All three of the mentioned interventional groups have corresponding control groups that will receive symptomatic treatment and comprehensive counseling. The measured primary outcomes are pain and electromyogram, and the secondary outcomes include pain drawing, Graded Chronic Pain Scale, Jaw Functional Limitation Scale, Oral Behaviours Checklist, depression, physical symptoms, and anxiety. The outcome measurements will be recorded at baseline and at the end of 24 hours, 7 days, 28 days, and 3 months.


インド・高知のアムリタ医科大学のInstitutional Review Boardから倫理的承認を得た。試験参加者の募集は2021年5月に開始し、2023年3月に終了する予定である。本臨床試験プロトコルは、SPIRIT(Standard Protocol Items: Recommendations for Interventional Trials)2013年ステートメントに基づいて作成された。

RESULTS: Ethical approval was obtained from the Institutional Review Board of Amrita Institute of Medical Sciences, Kochi, India. Study participants' recruitment began in May 2021 and is expected to conclude in March 2023. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement.



CONCLUSIONS: The purpose of this study is to gather data on prosthetic rehabilitation as a treatment for TMD. Obtaining this goal will aid in the development of evidence-based therapy protocols for prosthetic rehabilitation in TMD management.


Clinical Trials Registry - India CTRI/2020/06/026169; http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=42381。

TRIAL REGISTRATION: Clinical Trials Registry - India CTRI/2020/06/026169; http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=42381.